Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K920694 |
Device Name |
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
BARSANTI |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
BARSANTI |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/14/1992 |
Decision Date | 03/23/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|